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14 Apr 2015,
Erik Vollebregt
The EU ombudsman is urging the European Commission to reexamine allegations that Greek hospitals violated procurement laws to favor certain suppliers, saying the country has a history of flouting the law. The…

Article

11 Mar 2015,
Erik Vollebregt
The UK Medicines and Healthcare products Regulatory Agency has issued guidance on how medical devices manufacturers can provide an electronic format of their instructions for use (eIFU). However, the guidance has come…

Article

16 Oct 2013,
Erik Vollebregt
This seminar addressed how to develop compliant medical software and how to prepare for increased scrutiny by the authorities. Speakers and their presentations: Robert Houtenbos, mHealth consultant How to design medical software…

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12 Sep 2012,
Carine van den Brink
Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips…